Inflammatory Bowel Disease Clinical Trial
Official title:
The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak and Short-term Outcomes in Robotic Colorectal Surgery: A Prospective Randomized Trial
In colorectal surgery, anastomotic leak and its septic consequences still remain as the most
concerning complications resulting in substantial morbidity and mortality. A common
determining factor for assessing the viability of a bowel anastomosis is adequate arterial
perfusion to ensure sufficient local tissue oxygenation. Intraoperative near-infrared
fluorescence (INIF) imaging using indocyanine green (ICG) dye is a novel technique which
allows the surgeon to choose the point of transection at an optimally perfused area before
creating a bowel anastomosis. Recently, the INIF imaging system has been installed on the
robotic systems and this helps identify intravascular NIF signals in real time.
Although reports from several case series and retrospective cohorts have described the
feasibility and safety of this imaging system during robotic colorectal surgery, to date, no
studies have addressed more systematically the outcomes of this technique in robotic
surgery. Considering the limitations of these reports, investigators aim to conduct a
prospective randomized trial to compare robotic procedures with or without INIF imaging in
patients undergoing colorectal surgery.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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